New EU health data space rules could flaw by some inconsistencies, experts say

The new EU health data space regulation is seeing the light, but many stakeholders are complaining that more measures are needed to ensure public trust and transparency and accelerate the adoption of interoperability standards across Europe. The topic was discussed during an event organized by the Digital Health Society (DHS) at the beginning of December 2024. The organization was born in 2017 as a legacy of the Estonian Presidency of the EU Council and promotes the interests of hundreds of players in the digital health policy field.

DHS is advocating for new actions to fill the existing gap and complete a legislative framework that unleashes the potential of the health data space in the EU. The DHS president, Dipak Kalra, regretted the lack of standardized formats for data publication and the absence of alternatives for processing data exclusively in secure environments.

The matter concerns the primary use of data, which refers to EU citizens’ access and control rights over their data for their health needs. Richard Bergström, Vice President for European Affairs at IQVIA, a service provider in biopharmaceutical development and professional consulting, took the floor and stressed the opportunity for data holders to obtain quality and utility labels to improve their standards. The European Commission is asked to adopt implementing guidelines to clarify these standards.

Kalra highlighted that the EHDS regulation reasonably addresses the issue of public trust, but inconsistencies remain when it comes to fragmentation across Member States on the right to exert an opt-out for the use of data. Exceptions exist in this last case concerning the use of data for situations of vital interest. The re-use of such data might also be limited by natural persons, except for specific purposes such as research in the public interest.

A number of other issues were raised, spanning from the challenges in understanding the new opportunities due to low trust to the implications of non-interoperable systems for citizen engagement and data literacy.

The EU health data space regulation is expected to succeed in its last legislative step, which consists of a formal vote of the 27 EU ministers scheduled for the meeting of January 21 on the final text agreed by the European Parliament and the EU Council Belgian rotating presidency in March 2024.

The final text includes the possibility for Member States to put in place stricter access rules to specific data, such as genetic data. Member States are also authorized to establish trusted data holders in charge of safely processing requests for access to health data.

The regulation will enter into force 20 days after publication in the EU’s Official Journal, following the signature of the President of the European Parliament and the Presidency of the EU Council.